KR20180025983A - Apparatus for purging catheter systems - Google Patents

Abstract

A method and apparatus are provided for providing a controlled pressure-flow pulse that purges a catheter system with turbulent flow flushing. The achievement of this controlled pressure-flow pulse is achieved by the use of a special plunger rod of a conventional syringe, another interacting portion of a conventional syringe, an inline catheter attachable device that automatically generates a controlled pressure-flow pulse, This is accomplished by various devices of the present invention including a finger-operated device.

Description

[0001] APPARATUS FOR PURGING CATHETER SYSTEMS [0002]

The present invention is directed to an apparatus and method for cleaning a catheter system (e.g., an intravenous line) by creating a controlled and constant turbulent flushing pressure and flow within the system to purge undesired residues from the line, More particularly, the present invention relates to an apparatus and method for generating such turbulent flushing pressures and flows substantially independently of clinical medical techniques.

[0002] Turbulent "start-stop" or "push-pause" flushing of an intravenous catheter, eg, a central venous catheter, purges material from the catheter such that blood sediments, blood residues, It is well known in intravenous therapy techniques to be an appropriate method to prevent accumulation. This accumulation can cause occlusion of some or all of the fluid pathways within the catheter system, requiring a method for purging the catheter that can be costly and potentially dangerous, or the entire catheter may have to be replaced. Often, such an occlusion can interrupt therapy (e.g., intravenous therapy), impairing patient health. In addition, the accumulation of residues in the catheter can increase the risk of infection by providing a microbial propagation medium. For this reason, health care providers are routinely and somewhat generally taught push-to-stop flushing.

In propulsion-discontinued (or turbulent) flushing, the clinician needs to alternately increase and decrease the associated infusion rate during flushing. However, it is well known that the efficiency and success of catheter purging using push-stop flushing is entirely dependent on individual perception, compliance and proficiency, and successful purging operations are often incomplete or problematic. For this reason, there are many users who can not effectively use this turbulent flushing, and some users do not use turbulence flushing at all because of lack of knowledge and value recognition.

In addition to using turbulence for catheter cleaning, other fluid-feeding mechanisms associated with syringes, pumps, and intravenous infusion also operate substantially in the laminar flow region. Even when pulsatile flow is used, the pressure and flow characteristics are constrained to be much lower than the turbulence and volumetric flow levels necessary for effective catheter purging.

In a wide range of syringe configurations, techniques for providing various types and types of periodic stops to a syringe plunger can be routinely found. Generally, a number of such stops are used to help precisely measure and dispense the syringe filler portion. Once this stop is reached, it is common for the plunger to be released to allow controlled substantial laminar flow to the next stop. In other words, such a stop is generally released without the intentional force calculated to propel the stopper with sufficient force for catheter purging. Other stops are commonly used to limit syringes to single use. Generally, as is common in disposable hypodermic syringes, these stops are hard and can not be overcome reasonably.

An example of a plunger stop for limiting injection of fluid from a syringe is found in U.S. Patent No. 4,642,102 to Hirofumi Ohmori (Ohmori), issued February 10,1987. Ohmori discloses a stop that engages a groove in the plunger rod associated with the plunger to stop the discharge from the syringe. After each stop, the plunger rod is completely stopped so that no excessive force can further drive the plunger rod. Similarly, U.S. Patent No. 5,024,661 to Harry Wender (Wender), issued June 18, 1991, discloses a disposable syringe having a groove along a plunger rod.

U.S. Patent No. 5,318,544 to John Drypen et al., Issued June 7, 1994, discloses a metering syringe with a plunger rod including a plurality of stationary surfaces. The stop surface is spaced to define a predetermined dose volume. Rotation of the plunger rod allows additional dispensing by diverting each stop.

U.S. Patent No. 5,059,181 to Robert B. Agran (Agran), issued October 22, 1991, also discloses a syringe assembly having a groove in a plunger rod, which is used for secondary use of the syringe assembly And is used to delay the secondary backward movement of the associated plunger rod. In a similar manner, US Patent 5,084,017 to John Maffetone (Maffetone), issued January 28, 199, discloses a disposable syringe with a notched plunger rod. The Maffatone syringe works smoothly, but it decomposes itself at the end of one cycle of use.

U.S. Patent No. 5,280,030 to Cesar G. Corsich (Corsich) et al., Issued October 5, 1993, discloses a hypodermic syringe having a blockable piston that can prevent recharging and re-use under certain conditions .

U.S. Patent No. 5,328,476 to James Bidwell (Bidwell), issued July 12,1994, discloses a disposable hypodermic syringe device. The ratchet groove in the associated plunger rod is used as a lock member to prevent the plunger from retracting relative to the casing when the plunger is fully inserted or reinserted into the casing.

U.S. Patent No. 6,283,941 to Joel Schoenfeld (Schoenfeld) et al., Issued September 4, 2001, discloses a rod-shaped syringe plunger having a plurality of bead-shaped ratcheted teeth. Schoenfeld is also launching a disposable syringe. In particular, it should be noted that "it is a further object of the present invention to provide a disposable syringe having a plunger retraction force and smooth mechanical operation that is smaller than the industry maximum standard". This object is generally maintained in the syringe technology for manipulating the syringe plunger rod.

U.S. Patent No. 5,891,052 to L. Simmons (Simmons), issued on April 6, 1999, teaches a sabot lock and a syringe plunger guard located within the syringe body, And is selectively movable between unlocked positions. Thereby, a coupling is made to create a vacuum to extract the material into the syringe body.

U.S. Patent No. 6,488,651 to David Paul Morris (Morris) et al., Issued on December 3, 2002, discloses a plunger rod agitator (not shown) which permits flow in a barrel to allow material to communicate with materials in a more proximal chamber, And a syringe. Other cylinder barriers are provided in the chamber forming a space that is selectively displaced by movement of the plunger rod. Other retarding forces are not taught except for fluid dynamics and friction resistance (and static friction).

U.S. Patent No. 6,579,269 to Gennady I. Kleyman (Kleyman), issued June 17, 2003, discloses a dosimetry syringe. The plunger rod as taught in the Kleyman patent has a formation that increases the resistance to plunger displacement and produces an audible sound corresponding to a predetermined volume of the metric. Even so, the Kleyman patent has no teaching to provide a temporary stop to create a predetermined amount of turbulent flow in the catheter.

U.S. Patent No. 5,685,864 to Laurence M. Shanley (Shanley) et al., Issued November 11, 1997, discloses an aspiration syringe device that is operated to invert aspirated without releasing it to the site of connection. The right-handed stem of the associated plunger is provided with spaced flanges. At least one stop is provided in the syringe barrel. When the flange comes into contact with the stop, the advance of the plunger is disturbed. Rotation of the plunger enables further processing.

U.S. Patent No. 4,995,869 to Martin McCarthy (McCarthy), issued February 16, 1991, discloses a disposable hypodermic syringe. The syringe barrel according to the McCarthy patent has an inner corrugated surface which is moved rearwardly thereon under the influence of the hydraulic force of the skirt portion toward the base end. It is evident that the corrugations cause pulsations in the flow while discharging the fluid through the patient's needle, but it is clear that there is no relevant teaching about creating a turbulent flow in the catheter, a topic not mentioned in the McCarthy patent.

In general, in summary, the prior art, cited as an example, teaches a plunger rod with slots, grooves and ratcheting teeth, which is useful for measuring a predetermined volume of dispensed fluid or for providing a disposable syringe So as to provide an obstacle used for the stop. As with the clinical-dependent creation of propulsion-discontinuous flows, there is no teaching in all these techniques to ensure successful generation of turbulent flow to clean the associated attached catheter system. This is the specific and precise purpose of the present invention.

Briefly summarized, this novel invention is based on all the notifications for providing a controlled, consistent throttle effective to generate a controlled, pre-determined propulsion-discontinuous pressure and flow, thereby purging the material disposed within the catheter system Alleviate the problem. The present invention includes an apparatus and method configured and configured to create a pressure resulting from dynamic release by a predetermined force, which includes a controlled and constant < RTI ID = 0.0 > Provides a surge.

Typically, this flow is provided to the catheter system from a flushing liquid source from a container sized to hold a volume of liquid that conforms to the fluid volume requirements of the desired pressure pulse. In each case, the actuator opens the valve mechanism at a predetermined pressure to initiate the desired liquid pulse pressure and the final liquid flow. The sensing actuator has a working hysteresis that eventually stops the flow to terminate the pressure pulse. Of course, the means, for example pump or piston, is an important part of the device to provide sufficient pressure to operate the valve mechanism. To keep the proper pressure across the pulse, the memory element provides a source of stored energy received from the means and releases the stored energy upon opening the valve mechanism to maintain turbulent flushing fluid pressure and flow during the desired pulse period.

One embodiment of the present invention is to apply the present invention to a syringe, and more particularly to a plunger rod of a syringe. In this case, the barrel of the syringe is a container. Displacement of the plunger rod (and associated plunger) within the barrel serves as a means for dispensing liquid from the syringe. A retaining ring with a reduced diameter relative to the diameter of the rest of the syringe barrel is generally found at the proximal end of a conventional syringe. This retention ring is used as a tactile indicator between the inlet discs disposed on the stem of the plunger rod at the proximal end directly from the plunger attached to the plunger rod to prevent the plunger bar (and the plunger) .

At least one actuating geometrical feature with a predetermined force in the required size and shape to displace the actuating geometric feature over the retaining ring is disposed at the proximal end on the stem against the entrance disc. Pushing the actuation geometry through the retaining ring creates the force required to provide the desired turbulent flushing fluid pressure and initiate flow. This geometry may be an interfacing nub on the outer edge of the shaft of the disc or plunger rod on the plunger. The reflexive movement associated with pushing the operating disc past the retaining disc provides the memory based storage energy needed to ensure the ensuing duty of the forced flow thereby providing a pressure pulse. The length of the pressure pulse can be adjusted by either displacing the plunger to empty the syringe barrel, or by pushing only through the retention ring to provide a tactile measurable stop on the second operating disc, Lt; / RTI > Note that the resistance of this stop to the reflective energy applied to displace the syringe plunger rod provides the specified hysteresis. In this manner, a conventional syringe barrel in combination with a plunger rod manufactured in accordance with the present disclosure can provide the desired pulse-stop pressure pulse from the syringe substantially independently of the syringe user. It may be desirable to provide a segment of the plunger rod without an actuating geometry feature to provide a "pulse free" segment to enable a conventional flush technique to check for possible occlusion and to verify blood return.

In another embodiment, a pulse-stop pressure pulse is provided by the inline device. The fluid source is a reservoir having a sufficient volume to fill the vessel in which the pressure pulse is generated, and the vessel is a hollow cylindrical vessel that receives liquid from the reservoir through the one-way valve. The communication for dispensing the liquid to the catheter system is via another one-way valve.

The valve mechanism is a plunger sized and shaped to displace the fluid in the vessel into a catheter system through a one-way valve. The vessel also has a retaining ring similar to the retaining ring of the barrel of a conventional syringe. A valve actuated disk associated with the plunger is configured in a size and shape that requires the predetermined force required to produce a desired pulse toward the catheter system. The volume of the vessel determines the pulse volume. Also, as in the case of a syringe, the reflection action resulting from the release of the force when the operating disc is driven past the retaining ring ensures an appropriate pulse pressure. Actual means for driving the plunger are derived from the associated rod and button attached to the plunger, whereby the plunger is manually driven through the plunger. A spring arranged to be compressed when a pressure pulse is generated stores energy to recharge the vessel and return the plunger during a subsequent pulse-stop cycle.

Another embodiment of the present invention includes a pressure responsive switch having an actuator that opens the valve at a higher predetermined pressure and closes at a lower predetermined pressure. Generally, the source is a fluid reservoir upstream from a pressure providing device that provides a fluid to be dispensed at a predetermined pressure and flow. The vessel functions as a vessel communicating with the pressure providing device through the fluid restrictor. The vessel also communicates with the catheter system via a pressure sensitive valve. The pressure sensitive valve is selected to have an opening pressure that provides a fluid pulse with the desired turbulent flow characteristics and is closed at a pressure after the desired volume is achieved and the pressure in the vessel is reduced below a lower predetermined pressure.

In another embodiment, the pump provides the pressure of the source. A spring loaded in the piston chamber provides an opportunity to secure a volume for the pressure pulse, which flows through the flow restrictor attached to the output of the pump at a pressure lower than the higher predetermined pressure and lower than the lower predetermined pressure It is charged at high pressure. Thus, the higher predetermined pressure is reached only when charging the chamber. Once the chamber is filled, the valve is opened by the actuator to initiate the controlled pressure pulse. When the chamber is emptied, the pressure in the vessel falls below a lower predetermined pressure and the actuator closes the valve. If this embodiment remains attached to the catheter system, a subsequent pressure pulse is automatically generated.

Another of the other embodiments includes a compressible tube. In this case, the tube communicates with the catheter system through a pressure responsive valve having a valve actuator opening characteristic as described above. At the upstream, the tube communicates with the source via a one-way valve. The pressure from the source can not reach or exceed a higher predetermined pressure, but is sufficient to fill the tube. Thus, the pressure from the elastic memory and the upstream source in the tube causes the tube to be charged through the upstream one-way valve. Once the tube is properly filled, it is selectively compressed so that the pressure is raised to at least a higher predetermined pressure. After the pressure in the tube is at or above a predetermined pressure, the valve is opened and a pressure pulse is initiated. The pressure pulse is continued by a reflex action followed by a valve opening. Extraction of liquid from the tube eventually closes the valve and stops the pressure pulse. The pressure pulse may continue until the tube is substantially empty.

A method for using an embodiment of the present invention generally comprises filling a chamber or a vessel of a predetermined size to which a liquid pulse is dispensed, causing the pressure in the chamber or vessel to exceed a predetermined pressure, And selectively opening the path to the catheter system. In this manner, a desired controlled pulse-stop pressure pulse is achieved and is provided substantially independently of the user's performance.

It is therefore a principal object to provide a device that provides a substantially user-independent controlled pulse-stop pulse flow of sufficient turbulent flushing pressure and flow within the catheter system to substantially purge unwanted residues from the line.

It is a principal object to provide such a device for use in the barrel of a conventional syringe.

Another primary purpose is to provide such an apparatus that provides in-line operation between the fluid source and the catheter system.

It is an object to provide such a device for providing a series of manually generated pulse-stop pressure pulses.

An important objective is to provide such a device using a pump as a means.

Another object is to provide an apparatus for providing a controlled pressure pulse resulting from opening and closing a pressure sensitive valve.

These objects and features of the present invention will become apparent from the detailed description of the invention with reference to the accompanying drawings.

Definition of some terms used in the specification

Catheter system (n.): A combination of a tube and other device used to deliver fluids to a patient, such as a medical catheter (e.g., a vein catheter), a delivery tube (e.g., a delivery tube) .

Fluid (noun): gas or liquid.

IV (adjective): A method of delivering fluid to a patient, in this case the method is intravascularly ingested.

Laminar flow (noun): A relatively smooth, uniform streamline flow as opposed to turbulent flow, close to the solid boundary.

Turbulence (noun): Fluid flow in which the velocity is randomly varied in magnitude and direction over time, at a given point, and is inherently pattern-variable and contrasts with laminar flow.

Valve mechanism (n.): A fluid control device generally designated as an apparatus that initiates a pressure pulse in an open mode and terminates a pressure pulse upon occlusion, wherein, within this general definition, a syringe plunger rod displaced to actuate a pressure pulse The pulse-pressure generating action of the valve is thought to be a valve mechanism.

1 is a perspective view of a syringe and a plunger rod manufactured in accordance with the present invention having a plurality of discs with a stem of the plunger rod disposed on the length thereof.
Figure 2 is a cross-sectional view of the syringe and plunger rod shown in Figure 1;
Figure 2a is a cross-sectional view of a syringe and plunger rod similar to the syringe and plunger rod of Figure 2 wherein the edge of the disc is configured to easily displace the plunger rod into the syringe and to prevent the plunger rod from being removed from the barrel once it is displaced .
FIG. 2B is a cross-sectional view of a syringe and plunger rod similar to the syringe and plunger rod of FIG. 2 wherein the edge of the disc is configured to readily displace from the syringe after the plunger rod is displaced inward.
FIG. 2C is a cross-sectional view of a syringe and plunger rod similar to the syringe and plunger rod of FIGS. 2, 2A, and 2B, but with a nub along the shaft of the plunger rod instead of a disk.
Figure 3 is a perspective view of the plunger rod shown in Figure 1;
4 is a perspective view of a syringe and plunger rod, wherein the plunger rod is similar to the plunger rod of Fig. 1, but is made of a plurality of breakaway rings disposed around the stem of the plunger rod.
5 is a perspective view of the plunger rod shown in Fig.
Figure 6 is a perspective view of the syringe and plunger rod shown in Figure 4 with at least one separation ring removed from the stem of the plunger rod.
7 is a perspective view of a syringe and plunger rod, wherein the plunger rod is similar to the plunger rod of Fig. 1, but has a constraining elastomer ring around the syringe barrel opening adjacent to the wave pattern on the stem.
8 is a cross-sectional view of the syringe, plunger and elastomer ring shown in Fig.
9 is a perspective view of an automatic in-line pulsing apparatus according to the present invention.
10 is a cross-sectional view of the automatic in-line pulsing device shown in Fig. 9 showing the state of the device at the pulse end;
FIG. 11 is a cross-sectional view of the automatic pulsing apparatus shown in FIG. 9 showing the state of the apparatus when it is loaded prior to activating the pulse.
12 is a cross-sectional view of the automatic pulsing device shown in Fig. 9 showing the state of the device during pulse generation.
Figure 13 is a perspective view of the device shown in Figure 9 with a syringe attached to the device to provide a fluid pressure source.
14 is a schematic diagram of a system using a pumped fluid source for the apparatus shown in FIG.
15 is a perspective view of a squeezable device for providing a controlled pressure pulse according to the present invention.
16 is a cross-sectional view of the apparatus shown in Fig.
Figure 17 is a cross-sectional view of the device shown in Figure 14 where the medical section is squeezed at the end of the controlled release pressure pulse.
Figure 18 is a perspective view of a manually actuated control pressure pulse device made in accordance with the present invention.
FIG. 19 is a cross-sectional view of the apparatus shown in FIG. 18 being charged prior to initiating a controlled pressure pulse.
20 is a cross-sectional view of the apparatus shown in Fig. 18 at the end of the pressure pulse.

In the description of the invention, the term "proximal" is used to indicate the portion of the device generally closest to the object of the sentence describing its location. The term " distal "means the position opposite the proximal portion. Reference will now be made to the embodiments shown in Figs. 1 to 20, wherein like reference numerals are used to refer to like parts throughout.

Reference is now made to Fig. 1, in which a preferred embodiment of a syringe / plunger rod assembly 10 of the present invention is shown. Combination 10 includes a conventional syringe barrel 20 and a plunger rod 30. The salient features of the combination 10 include a barrel 20 having a retaining ring 40 disposed at the proximal barrel opening 42 as best seen in Figure 2, And a plunger rod 30 comprising an interface or ring that is generally a plurality of actuating geometric features indicated generally at 50. The plunger rod 30 also has a plunger 70 attached to the distal end 80 of the stem 60, as is common with the plunger rod of a conventional syringe. The distal end 80 is provided with a threaded portion 90 that allows the plunger rod 30 to be attached to the plunger 70 after the barrel 20 is filled with a liquid, . The plunger rod 30 is shown separately in Figure 3 where the threaded portion 90 is shown more clearly.

The plunger rod 30 also has a first ring 92 that can be pushed past the retaining ring 40 when the plunger 70 and the stem 60 are inserted into the barrel 20. The first ring 92 is formed to a size that can be pushed into displacement through the retaining ring 40 but provides a tactile identifiable stop to prevent the plunger 70 from being inadvertently displaced out of the barrel 20 do.

Each actuator ring 50 is formed in a size and shape that is obstructed by the retaining ring 40. In addition, each actuator ring 50 is formed in a size and shape that requires a predetermined force that must be exceeded to displace the contact actuator geometry (e.g., retention ring interface 50) past retention ring 40 have. For this reason, the fluid in the barrel 20 is displaced by the resultant acceleration and velocity due to the predetermined force when the contact ring 50 is releasably displaced through the retaining ring 40. Generally, the resulting acceleration and velocity is for the liquid exiting the syringe barrel 20 through the associated catheter system to flush the liquid 72 in a turbulent fashion. In this manner, each time the contact ring 50 is displaced past the retaining ring 40, a pulse of pressurized liquid 72 is purged into the catheter system to provide a turbulent flushing pulse of liquid 72 therethrough.

The more proximal ring 94 of the ring 50 is also configured to provide a reminder that the pulse due to the actuation use ring 94 is the last pulse provided by the liquid 72 from the combination 10. [ A force larger than the ring 50 at the distal end is formed in a required size and shape. For this reason, the ring 94 may be referred to below as the indicator ring 94. If the plunger rod 30 is not displaced far enough into the barrel 20 to displace the indicator ring 94 past the retaining ring 40 then any back flow or reflux within the associated catheter system (reflux) does not occur. Note that the proximal end 98 of the stem 60 is convex or dome shaped to facilitate the application of finger force to the plunger rod 30.

It should also be noted that ring 50 need not be evenly spaced. By way of example, the space 99 between the first ring 92 and the adjacent starter ring 50 is relatively large compared to the space between other rings, generally referred to as 50. This provides a "no pulse" portion that can be used for conventional samples for catheter blood flow to ensure proper catheter operation.

Now, consider FIG. 2A, in which a combination 20 'of a conventional syringe barrel 20 and a plunger rod 30' is shown. The plunger rod 30 'is similar to the plunger rod 30 and includes a series of actuator rings 50' disposed along its length. However, in the case of the combination 10 ', the ring 50' is easier to move into the barrel 20 (and through the retaining ring 40 to the distal end) than to displace the barrel 20 through the retaining ring to the proximal end (See Fig. 2A). This satisfies the condition that the plunger rod 30 'is not easily removed from the barrel 20 once it is used to promote single use application.

On the other hand, it may be desirable to recharge and reuse such a combination. In this case, it is desirable to more easily displace the plunger rod 30 "of the third combination 10" toward the proximal end than the distal end. In this case, the actuating ring 50 "placed along the stem 60 is shaped as shown in Fig. 2B.

The ring 50 shown in Fig. 2 can be replaced by a nub 52 on the plunger rod 32, as can be seen in the combination 12 of Fig. 2C. By forming the nubs 52 to a predetermined size and shape so as to require a force similar to that required to displace the ring 50 past the retaining ring 40, the effect of creating the desired turbulence is not degraded, The replacement of the ring 50 by the ring 50 can be performed.

Another embodiment as shown in the combination 110 of the present invention is shown in Figs. 4-6. As in the combination 10, the combination 110 includes a conventional syringe barrel 20. Note that the syringe barrel 20 has a proximal inlet opening 122 associated with the retaining ring 40. As shown in FIGS. 4 and 5, the associated plunger rod 30 also includes a series of actuator rings, generally designated 150 and arranged along the stem 60 of the plunger rod 130. Rather than being formed in a size and shape that is pushed through the retaining ring 40 of the barrel 20 to create the desired pressure pulse, The ring (150) is attached to the stem (60) in such a manner that it is sheared away from the stem (60).

The shear forces in the separate actuation rings 150 from the stem 60 may be used to release and purge unwanted contaminants from the downstream catheter system similar to the displacement force through the retention ring 40 of the combination 10 Is geometrically and mechanically designed to provide a predetermined acceleration and velocity to supply the desired turbulent flow. 6, the first actuator ring 150 disposed at a more distal end is illustrated as being captured by the second actuator ring 150 disposed at the base end rather than outside the hole of FIG. Accumulation of the sheared actuation ring 150 is used to prevent the syringe from being fully released.

Yet another embodiment of the present invention is shown as a combination 210 in which a conventional syringe barrel 20 shown in Figs. 7 and 8 can be used. In addition to the barrel 20, the assembly 210 includes an elastomeric restrictor 230 and a plunger rod 240 having a stem 242. The stem 242 includes a plurality of elongated side members 244, respectively. Each side member has a corrugated outer edge, indicated generally at 246. The high point of the waveform is indicated generally at 248.

The restrictor 230 is configured and configured to provide a port around the barrel inlet opening 42 (see Figures 1 and 2). The restrictor inlet aperture 250 is sized and shaped to prevent the inward displacement of the plunger rod 240 upon collision between the restrictor 230 and each apex 248. The combination of the selected durometer of the elastic limiter 230 and the impingement geometry of the hole 250 and the peak 248 is combined to require a predetermined force for further displacement of the plunger rod 240. This predetermined force corresponds to the force required to displace the plunger rod 30 through the retaining ring 40 (see Figures 1-3). In this manner, a pressure pulse is generated that provides a turbulent flow for purging the attached catheter system every time the high point 248 is displaced through the aperture 250 of the restrictor 230.

Reference is now made to Figures 9-12, in which an in-line automatic pulse device 310 made in accordance with the present invention is shown. As shown in FIG. 9, the device 310 includes an upstream or proximal connection 320 into which liquid is supplied from a liquid source. In addition, device 310 includes an output port and connector 330 that can be connected to a downstream catheter system. For proper operation, the liquid pressure available from the source must be greater than the desired pressure of the purge liquid pulse being diverted by the device 310. [

As shown in FIG. 10, when the pressure is less than the desired pressure, a pressure sensitive valve 340 is disposed to close the output port and connector 330. A check valve 350 is only distal from the proximal connection 320 to delay the inflow to a certain level of flow and disturb the backflow. A pulse storage chamber 360 is disposed between the pressure sensitive valve 340 and the check valve 350 in the middle. A piston 370 and a spring 380 act in the chamber 360 to store a certain volume of liquid when the valve 330 is closed is disposed within the chamber 360.

When selecting the pressure sensitive valve 340, a valve having an open pressure versus closed pressure hysteresis with a predetermined pressure differential for the purposes described below should be selected. The pressure difference is defined as the difference between high release pressure and low release pressure. High pressure is the pressure that produces a pressure pulse with sufficient force and flow to cause downstream turbulence to pour the desired amount of material from the attached catheter system. The low pressure is the pressure at which the pressure in the device 310 drops after removing liquid from the chamber 360. Note that for the pressure of the interior 310 falling to low pressure, the inflow from the source should be limited to a lower flow rate than the outflow through the output port and connector 330.

The actuation phase of the device 310 is shown as implementing the start state shown in Figure 10, in which the chamber 360 is empty, the spring 380 is depressurized, and the valve 350 is closed. A subsequent filling of the chamber 360 is shown in FIG. When the spring 380 is fully depressed thereby thereby discharging liquid from the device 310, the valve 340 is opened. Of course, once the valve 350 is closed, the pulse cycle is repeated.

The pressurized fluid source of the device 310 is shown in Figures 13 and 14. [ In Fig. 13, a conventional syringe 390 is attached to the proximal connecting portion 320. Fig. The source pressure is provided by the force displacing the associated plunger rod 392. Note that sufficient pressure is required to sufficiently discharge the chamber 360 prior to actuating the valve 350.

14, a more sophisticated pressure source system including a salt bag 304, a pump 396 and a variable liquid flow restrictor 398 is shown. The source liquid from the bag 394 is sucked and pumped by the pump 396 to provide the same or greater pressure that is needed to open the valve 350. The variable restrictor is set to determine the pump transfer rate of the pump (396) to the device (310) to determine the output pulse rate of the device (310).

Reference is now made to Figs. 15-17, in which an inline pinch or compression pump 410 made in accordance with the present invention is shown. As shown in FIG. 16, the apparatus 410 includes an upstream or proximal connection 420 through which liquid is supplied from a liquid source. In addition, the device 410 includes an output port and connector 430 that can be connected to a downstream catheter system. For proper operation, the liquid pressure available from the source must be greater than the fill pressure of the inflatable tube 440 formed in a size and shape that can be easily filled and purged by compression.

16, the pressure sensitive valve 340 (see also Figs. 11-13 of the above-described apparatus 310) is configured such that when the pressure is below a predetermined pressure, the output port and connector 430 are closed, As shown in Fig. A check valve 450 is distal from the proximal connection 420 to obstruct the backflow. The tube 440 provides a storage medium that defines the amount of pulse flow when the apparatus 410 is actuated. To operate, the tube 440 is compressed until the valve 340 is opened to provide a pressure pulse according to the present invention. Continued reflex compression dispenses liquid through valve 340 to produce pulsation of the liquid flow with sufficient turbulence and pressure to pour the attached catheter system. The pressure of the source liquid requires only a pressure high enough to fill the tube 440 and the tube 440 may have sufficient unique structural memory to provide somewhat negative fill pressure requirements. This same memory reduces the liquid pressure in the tube 440, causing the valve 340 to close at the end of the pulse generation cycle.

Another device 510 that provides a controlled pressure pulse generated by the fingers manually for purging the catheter system in accordance with the present invention is shown in Figures 18-20. As shown in FIG. 19, the apparatus 510 includes an upstream or proximal connection 520 into which liquid is supplied from a liquid source. The device 510 also includes an output port and connector 530 that can be connected to the downstream catheter system. For proper operation, the available liquid pressure from the source must be greater than the fill pressure of the spring piston assembly 540. Combination 540 includes a decompression button and rod 550, a compressible spring 560, and a plunger 570. The plunger 570 is adapted to discharge liquid from the hollow vertical chamber 580 that is in direct communication with the hollow liquid flow chamber 590 disposed for liquid communication between the base connection 520 and the output port 530 And is formed in a predetermined size and shape. The amount of liquid stored in the vertical chamber 580 and released upon displacement of the plunger 570 determines the pulse volume of liquid delivered to the downstream catheter system.

As shown in FIG. 19, the pressure sensitive valve 340 (see FIGS. 11-13 of the above-described apparatus 310) is configured to close the output port and connector 530 when the pressure is below a predetermined pressure . A check valve 450 is at the distal end from the proximal connection 520 to obstruct the backflow. To actuate the device 510, the button 550 is depressed to open the valve 340 to provide a pressure pulse according to the present invention. A coherent reflective pushbutton 550 dispenses liquid through the valve 340 to create a pulsating flow of liquid with sufficient turbulence and pressure to purge the attached catheter system. The pressure of the source liquid must be sufficiently high to fill the chamber 580 and the combination 540 with the spring 560 should have sufficient inherent structural memory to provide a negative filling pressure within the chamber 590 . This same memory reduces the liquid pressure in the chamber 590, causing the valve 340 to close at the end of the pulse generation cycle.

To operate the device 510, the chamber 580 may be filled with liquid provided through the connector 520. Pressing button 550 to provide the required force to open valve 340 and until fluid is purged from chamber 580 as shown in Figure 20 to create the desired purge pressure pulse, Then press the button continuously. Once the combination 540 is fully depressed, a force on the button 550 is removed to allow recharging of the chamber 580 to create a subsequent pressure pulse.

The present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. Accordingly, the embodiments of the present invention should be considered in all respects as illustrative and not in all aspects, and the scope of protection of the present invention is defined by the appended claims rather than by the foregoing description of the invention, All changes that come within the meaning and range of equivalency are intended to be embraced within the scope of protection of the present invention.

Claims (15)

Flush syringe,
A barrel including a proximal opening and a restrictor disposed in the proximal opening to create a restrictor inlet,
Wherein the plunger rod includes a stem having a plurality of elongated side members and wherein the elongate side member is adapted to displace the plunger rod into an end within the barrel And a plurality of high-point portions that collide with the limiter to require a predetermined force for the high-
Flushing syringe. 2. The apparatus of claim 1, wherein the barrel
Flushing syringe. 3. The method of claim 2, wherein the liquid is a flush fluid
Flushing syringe. 3. The method of claim 2,
The barrel may be filled with a predetermined amount of liquid that provides a turbulent flow to the liquid as the plurality of high-
Flushing syringe. 3. The method of claim 2,
The restrictor includes an elastomer having a selected hardness that provides a turbulent flow in the liquid when the high point portion is displaced through the restrictor inlet
Flushing syringe. The method according to claim 1,
The stem of the plunger rod includes a space between the plurality of high point portions that prevents acceleration and velocity in the barrel when the plunger rod is displaced to the distal end in the barrel
Flushing syringe. The method according to claim 1,
The restrictor inlet is sized and shaped to impede the inward displacement of the plunger rod upon impact between the restrictor and the high point
Flushing syringe. The method according to claim 1,
Wherein the plurality of high point portions and the restrictor inlet have a collision geometry
Flushing syringe. 9. The method of claim 8,
The collision geometry of the plurality of high point and restrictor inlets and the selected hardness of the elastomer of the restrictor require a predetermined force for displacement of the plunger rod
Flushing syringe. The method according to claim 1,
The restrictor is configured to provide a port near the base opening of the barrel
Plunger rod. An apparatus for providing a controlled, constant propulsive-stop pulsating flow in a catheter system, the turbulent flushing pressure and flow sufficient to substantially purge unwanted residues from the line,
A flush fluid supply source;
A proximal connection for connecting to the flush fluid supply;
A container for holding a predetermined volume of flushing fluid;
An output port and connector for connection to the catheter system;
A housing for receiving the vessel, the pressure sensitive valve, the check valve and the pulse storage chamber;
Means disposed within the pulse storage chamber and a memory element,
Wherein the pressure sensitive valve is disposed at the output port and the connector base and is automatically opened at a predetermined first pressure causing a sufficient turbulent flow of the flush fluid from the vessel and automatically opened at a predetermined second pressure lower than the predetermined first pressure And a working hysteresis disposed to close the output port and the connector to controllably impede flow communication of the flushing fluid between the vessel and the catheter system;
The check valve being disposed at an end of the proximal end connection to interfere with the back flow of the flush fluid of the container and to delay the inflow from the flush fluid supply to a predetermined level of flow within the housing;
Said pulse storage chamber being disposed intermediate said pressure sensitive valve and said check valve;
Wherein the means disposed in the pulse storage chamber provides at least sufficient fluid force to generate a predetermined first pressure in the vessel necessary to open the pressure sensitive valve;
Wherein the memory element stores energy received from operation of the means and releases stored energy upon opening the pressure sensitive valve such that the pressure in the container is reduced from the flow and from the vessel during a period of time dependent upon the pressure exceeding a predetermined second pressure. To provide a predetermined first pressure to generate a sufficient turbulent flow of the flush fluid of the flushing fluid,
An apparatus for providing controlled and constant propulsion-stop pulsating flow. 12. The method of claim 11,
The source comprising a flush fluid reservoir upstream from the pressure providing device, the flush fluid reservoir providing a flush fluid dispensed at a predetermined first pressure and flow;
Said vessel comprising a vessel, said vessel communicating with said pressure providing device through a flow restrictor and communicating with said catheter system via said pressure sensitive valve;
The check valve includes a valve closing operation at a predetermined first pressure and a valve closing operation at a predetermined second pressure;
Wherein the means comprises the pressure providing device acting through the flow restrictor to fill the container and raise the pressure in the container to a predetermined first pressure wherein the pressure providing device is operable to dispense Providing a flushing fluid; And
Wherein the memory element comprises a compressible element disposed at a proximal end of the plunger element and the plunger element is displaced by pressure and flow from the pressure providing device through the flow restrictor to accumulate a controlled and constant pressure and volume, To provide a target pressure pulse to purge
An apparatus for providing controlled and constant propulsion-stop pulsating flow. 13. The apparatus according to claim 12, wherein the pressure providing device comprises a pump
An apparatus for providing controlled and constant propulsion-stop pulsating flow. CLAIMS What is claimed is: 1. A method for providing a controlled propulsive-stop pulsating flow of a turbulent flushing pressure and flow in a catheter system to purge undesired residues from the line,
Providing the apparatus of claim 11;
Filling the vessel with a flushing fluid from a source;
Providing a force through the means to create a fluid opening pressure in the vessel to open the pressure sensitive valve at a predetermined first pressure;
Dispensing a flushing fluid having a predetermined turbulence pressure and flow for a predetermined period into the catheter system; And
Closing the pressure sensitive valve if the pressure in the container is reduced to a level below a predetermined first pressure
A method for providing controlled propulsion - stop pulsating flow. 15. The method of claim 14,
The source comprising a fluid reservoir upstream from the pump;
The vessel comprising a vessel, the vessel communicating with the pump via a flow restrictor and the vein (IV) line through the pressure sensitive valve;
Said means comprising a pump acting through said flow restrictor to fill said container and raise the pressure in said container to a predetermined pressure;
Wherein the memory element comprises a compressible element disposed at a proximal end of the plunger element and the plunger element is displaced by pressure and flow from the pump through a flow restrictor to accumulate a controlled and constant pressure and volume, To provide a target pressure pulse for < RTI ID = 0.0 >
Attaching the container to the catheter system;
Initiating pumping to charge the vessel at a rate dependent on the resistance of the restrictor and the pump output pressure to charge the vessel until a predetermined first pressure is reached;
To distribute the flushing fluid at a predetermined pressure and flow rate into a catheter system that purges undesired residues of the vein (IV) line with a pressure pulse having a duration that is terminated by the closing of the pressure sensitive valve at a predetermined second pressure. Opening the pressure sensitive valve when the determined first pressure is reached; And
Initiating the pumping until a target number of pressure pulses is delivered to the catheter system, and repeatedly repeating the step of opening the pressure sensitive valve upon reaching a predetermined first pressure
A method for providing controlled propulsion - stop pulsating flow.

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